(131 days)
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (TI to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
The Aleutian IBF System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LTI (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.
This 510(k) summary describes a spinal implant. The criteria and study described within are for establishing substantial equivalence for medical devices, not for an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and testing is not applicable.
Here's the information that can be extracted from the provided text:
Acceptance Criteria and Device Performance for Aleutian IBF System
| Acceptance Criteria Category | Description | Device Performance / Proof of Equivalence |
|---|---|---|
| Material Composition | Manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LTI (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads/rods to be Grade UNS R05200, UNS R05400 according to ASTM F560. | The Aleutian IBF System components are made of the same materials as components previously cleared in the Aleutian IBF System 510(k)'s K082698 and K101302 and to the DePuy AcroMed Bengal (K081917). Implied compliance with the stated material standards. |
| Dimensions & Configuration | Devices are available in a variety of different sizes and heights to match patient anatomy. Ends have machined teeth to engage vertebral body end plates. | The Aleutian IBF System components have similar dimensions and configurations as components previously cleared in the Aleutian IBF System 510(k)'s K082698 and K101302 and to the DePuy AcroMed Bengal (K081917). |
| Biomechanical Performance | Functions as an intervertebral body fusion device to provide support and stabilization. Designed to restore biomechanical integrity of the spinal column. | Finite element analysis was performed to demonstrate that the components added to the Aleutian IBF System in this 510(k) submission would not result in a new worst-case device under both compressive and torsional loading when testing per ASTM F2077. This demonstrates equivalent biomechanical performance. |
Regarding AI/ML Specific Questions:
This document is a 510(k) summary for a physical medical device (spinal implant), not an AI/ML device. Therefore, the following AI/ML-specific questions are not applicable (N/A) based on the provided text:
- Sample size used for the test set and the data provenance: N/A (No AI/ML test set mentioned)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
- Adjudication method for the test set: N/A
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A
- The sample size for the training set: N/A
- How the ground truth for the training set was established: N/A
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence comparison to previously cleared predicate devices (K082698, K101302, and DePuy AcroMed Bengal K081917).
- Methods:
- Material Comparison: Documentation was provided demonstrating that the subject Aleutian IBF System components are made of the same materials as the predicate devices.
- Dimensional/Configuration Comparison: The new components have similar dimensions and configurations to the predicate devices.
- Biomechanical Analysis: Finite element analysis was performed.
- Purpose of Finite Element Analysis: To demonstrate that the components added in this 510(k) submission would not result in a new worst-case device under both compressive and torsional loading when testing per ASTM F2077, indicating equivalent biomechanical safety and performance.
In essence, the study demonstrated that the new Aleutian IBF System is substantially equivalent to already marketed devices through material, dimensional, and biomechanical (finite element analysis) comparisons, rather than a clinical study with acceptance criteria often associated with novel technologies or AI/ML solutions.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.